FDA Is Critical Of Merck’s Vaccine Plant

We have learned that the drugs sold in the United States are oftentimes composed of byproducts that come from other countries. Unfortunately, we have also learned that there is very little oversight of the safety and efficacy of those byproducts. The recent scare relating to heparin is an indication of how poor the oversight actually is. Issues regarding the safety and cleanliness of our pharmaceuticals, unfortunately, are not limited to the byproducts coming from other countries.

The Food and Drug Administration recently sent a warning letter to Richard Clark, Merck’s chief executive officer, addressing sterility problems at Merck’s vaccine plant in West Point, Pennsylvania. The plant manufactures a number of children’s vaccines and a small number of adult vaccines. Because of sterility problems, the plant was forced to recall two vaccines in December 2007. Apparently, the sterility issue has not been resolved and that’s difficult to comprehend. One would think that the FDA would have followed up to make sure the problems were corrected.

The FDA cautioned Merck about a number of procedural violations and went further to state that Merck’s responses to the agency’s inspections and concerns were “inadequate to address the serious deviations” raised by its inspectors. The FDA has stated that it does not believe the sterility issues will affect the safety of the vaccines. Hopefully, that will prove to be an accurate assessment of what could be a most serious situation.